Characterization and Modulation of Traumatic Memories in PTSD Patients Using TMS

NCT06372639 | Completed DMC

• 1 other identifier: TAU-PTSD-TMS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Characterization and modulation of traumatic memories in PTSD patients using TMS.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (3)

• CAPS-5 score

  The CAPS-5 is a 30-item structured interview that can be used to make current (past month or week) diagnosis of PTSD \& make lifetime diagnosis of PTSD.

  Baseline, second measure after up to 12 weeks and last measure after up to 24 weeks.

• Neurological measures of functional connectivity

  Functional connectivity, indicating the level of synchronous activity of certain brain regions during rest (temporal correlation is usually expressed as a Pearson's r); Also to be derived from the MRI scans, and compared between the two groups over time.

  Baseline, after up to 12 weeks

• Intrusive memories

  The amount, frequency and emotional effect of intrusive traumatic memories, measured by a daily self-report of the subject.

  Daily for up to 12 weeks

Study Arms (2)

Hippocampus Stimulation

EXPERIMENTAL

Device: Trans-Cranial Magnetic Stimulation

Sham Stimulation

SHAM COMPARATOR

Device: Trans-Cranial Magnetic Stimulation

Interventions

Trans-Cranial Magnetic Stimulation DEVICE

Brain stimulation by the TMS device will be given after a deliberate memory re-activation, using repetitive pulses at 1Hz frequency for 15 minutes, the target area will be determined based on an fMRI scan in the resting state of the subject.

Hippocampus Stimulation; Sham Stimulation

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 20-65 of both sexes, who meet the diagnosis of PTSD according to DSM-5 as tested by a structured clinical interview (Clinician-Administered PTSD Scale - CAPS-5). The clinical interview will be performed by clinical psychologists.
• CAPS-5 (Clinician-Administered PTSD Scale) score higher than 33.
• Subjects who experience intrusive symptoms (flashbacks, nightmares, or intrusive memories) at least 4 times a week.
• Only subjects with a level of Hebrew that allows a full understanding of the consent form to participate in the experiment will be included in the experiment.

You may not qualify if:

• Subjects who meet the diagnosis of Complex PTSD or personality disorder.
• Subjects who suffer or have suffered in the past from a psychotic disorder, bipolar disorder, or a developmental neuropsychological disorder (autism, mental retardation).
• Use of psychiatric medications (except for the medications listed in section 4.a) will not be an expense criterion if the medication dosage is stable in the last three months and does not change during the study.
• Use of the following drugs:
• Subjects suffering from epilepsy or taking anti-epileptic drugs.
• Victims with traumatic head injuries or who have undergone head surgery.
• Having a metallic body (except fillings/amalgam bites/orthodontic fixations approved for MRI), electrodes or a pacemaker in their body.
• Subjects suffering from migraines
• Pregnant women
• Subjects with hearing problems
• Subjects who use drugs
• Subjects who drank alcohol 24 hours before the experiment
• Subjects who have previously experienced repeated episodes of fainting with loss of consciousness and/or an event of fainting with loss of consciousness in the past year. (reaction and vegalit)

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Tel Aviv University

Tel Aviv, 69978, Israel

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: February 23, 2022
• Primary Completion: October 24, 2024
• Study Completion: October 24, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

IL (1)